Controlling The Degradation Of Bioresorbable Metal Implants

ABSTRACT

A degradation controlled metal implant and methods of controlling the degradation of the implant. In one embodiment, the implant includes a body, one or more apertures, and one or more fastener blanks fixed within one or more apertures. In another embodiment, the implant includes a body of a first material and a second material plated in various patterns over the first material.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/378,747, filed Aug. 31, 2010, which is incorporated herein byreference in its entirety.

BACKGROUND OF THE INVENTION

The present invention relates to a degradation controlled metal implantand methods of controlling the degradation of the implant.

In the case of metals, the most destructive type of degradation resultsfrom electrochemical or galvanic attack, often thought of as beingchemical in nature. The terms “degradation” and “corrosion” are usedinterchangeably herein.

The use of degradable implant material is known in the art. However, dueto certain factors, including metal type and surface-to-volume ratio,certain implants either degrade too fast or degrade too slow. Thepresent invention addresses this problem.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to a degradation controlled metal implantand methods of controlling the degradation of the implant.

In at least one aspect, the present invention is directed towards animplant secured to tissue that includes a body including a firstmaterial and a plurality of apertures; a fastener disposed within atleast one of the plurality of apertures and secured to the tissues; anda fastener blank disposed within at least one aperture, the blank beingconfigured to substantially fill the aperture in which it is disposedwithout substantially protruding from the body.

In one embodiment, the fastener blank includes a screw head securelylocked to the body.

In another embodiment, the fastener blank includes a second materialthat is less noble than the first material.

In another embodiment, the fastener blank comprises a second materialthat is more noble than the first material.

In at least one aspect, the present invention is directed towards atissue implant that includes a body configured to be implanted intissue, the body comprising a first metallic material and a secondmetallic material, the first metallic material being more noble than thesecond metallic material.

In one embodiment, the body includes a cannulated fastener including thefirst metallic material, the cannulated fastener having a cannula, and awire insert including the second material, the wire configured toclosely fit within the cannula.

In another embodiment, a majority of the body is configured from thefirst metallic material and the second metallic material is welded orplated to the first metallic material.

In another embodiment, the body includes a plate having a plurality ofapertures substantially surrounded by the first material and aprolongation substantially including the second material.

In another embodiment, the second material comprises an alloy of thefirst material.

In another embodiment, a majority of the body consists essentially ofthe first material and a minority of the body consists essentially ofthe second material.

In another embodiment, the minority of the body reflects as one or morediscrete segments on a surface of the tissue implant.

In another embodiment, the one or more discrete segments include a line,a dot, a logo, a regular geometric pattern, an irregular geometricpattern or combinations thereof.

In at least one aspect, the present invention is directed towards amethod of controlling the degradation of a tissue implant includingproviding an implant having at least one aperture, the implant having abody consisting essentially of a first material; securing the implant totissue; and positioning an insert within the aperture to substantiallyfill the aperture, the insert consisting essentially of a secondmaterial that is of a lower nobility than the first material.

In at least one aspect, the present invention is directed towards amethod of controlling the degradation of a tissue implant includingproviding a first implant having a plurality of apertures and at leastone fastener blank; inserting fasteners through some but not all of theapertures to secure the plate to the bone; and after securing the plateto the bone, permitting the at least one fastener blank to be insertedin at least one of the plurality of apertures that do not contain aninserted fastener.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofembodiments of the present invention, will be better understood whenread in conjunction with the appended drawings of exemplary embodiments.It should be understood, however, that the invention is not limited tothe precise arrangements and instrumentalities shown.

In the drawings:

FIG. 1 illustrates an exemplary top view of a tissue implant accordingto one embodiment of the present invention;

FIG. 2 illustrates an exemplary top view of a tissue implant accordingto one embodiment of the present invention;

FIG. 3 illustrates an exemplary top view of a tissue implant accordingto one embodiment of the present invention;

FIG. 4 illustrates an exemplary cross-sectional view of the tissueimplant of FIG. 3 fastened to a tissue (e.g., bone) according to oneembodiment of the present invention;

FIG. 5 illustrates an exemplary top view of a tissue implant accordingto one embodiment of the present invention;

FIG. 6 illustrates an exemplary top view of a tissue implant accordingto one embodiment of the present invention;

FIG. 7 illustrates an exemplary top view of a tissue implant accordingto one embodiment of the present invention;

FIG. 8 illustrates an exemplary cross-section view of a tissue implantaccording to one embodiment of the present invention; and

FIGS. 9-11 illustrate exemplary top views of tissue implants accordingto one embodiment of the present invention.

FIG. 12 illustrates an exemplary cross-section view of a fastener blankaccording to one embodiment of the present invention.

FIG. 13 illustrates an exemplary top view of a fastener blank accordingto one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference to the accompanying drawings, various embodiments of thepresent invention are described more fully below. Some but not allembodiments of the present invention are shown. Indeed, variousembodiments of the invention may be embodied in many different forms andshould not be construed as limited to the embodiments expresslydescribed. Like numbers refer to like elements throughout. The singularforms “a,” “an,” and “the” include the singular and plural unless thecontext clearly dictates otherwise.

As shown generally in FIG. 1, embodiments of the present invention aredirected toward a tissue implant 100. In some embodiments, tissueimplant 100 includes a body 110 and one or more apertures 120. In oneembodiment, struts 140 surround or immediately abut apertures 120.

As illustrated in FIGS. 1-7, implant 100 may include a thickness 400such as the thickness of the plate illustrated in FIG. 4. Implant 100may include a linearly configured plate (e.g., as illustrated in FIG. 3)or a plate in an angular configuration (e.g., as illustrated in FIGS. 1and 2). Implant 100 is not limited however to a plate and may includeany other tissue implant. Implant 100 may further include one or morefasteners 200. Fasteners 200 may include threaded fasteners (e.g.,screws, cannulated screws); and non-threaded fasteners (e.g., wires,K-wires, cannulas).

In one embodiment, implant 100 includes fastener blank 130. Fastenerblank 130 may include a screw blank (e.g., a blind screw) or a boltblank (e.g., a blind bolt). In one embodiment, a screw blank or boltbank is a screw or bolt with a head that can be threaded for a specificapplication. In one embodiment, fastener blank 130 comprises a head withno shank. In one embodiment, fastener blank 130 has a uniform diameterthroughout its length. In one such application the screw head or bolthead is threaded to match threads in apertures 120. In one embodiment,fastener blank 130 includes a head that is configured to snap fit withinapertures 120. In another embodiment, fastener blank 130 includes a headconfigured to press fit within aperture 120. In one embodiment, fastenerblank 130 is configured to securely lock to body 110.

In one embodiment, fastener blanks 130 (e.g., blind screws) are used toprotect locking threads during bending (e.g., pre-bending) of an implantsuch as a plate. After the bending operation, the fastener blank 130 maybe removed and later replaced with fasteners such as a screw, bolt, orthreaded wire. In other embodiments, the fastener blank 130 may be leftin place after bending to be implanted as described herein. In one suchembodiment, the degradation rate of struts 140 is reduced orsubstantially eliminated where implanted fastener blanks are included inan implanted implant 100. In one embodiment, degradation is retardedmore from either the top or bottom of implant 100 when a fastener blank130 is implanted within an aperture with implant 100. In one embodiment,degradation of implant 100 occurs only from an outside face 150 ofimplant 100.

One example of fastener blank 130 is illustrated in FIGS. 12 and 13. Inone embodiment, fastener blank 130 has a predetermined height 1260, asubstantially saucer-shaped head 1210 and a body 1250. In oneembodiment, the head 1210 has a cross-shaped grove 1220 formed thereonso as to engage with the distal engaging portion of a rotary fasteningtool or a driver bit (not shown). In another embodiment, said head 1210has a predetermined width 1240. In one embodiment, said head 1210 has atapered side peripheral portion 1230.

Fastener blank 130 as illustrated in FIGS. 12 and 13 also includes abody 1250 extending downward from the head 1210. In one embodiment, saidbody has a predetermined width 1270. In one embodiment, the taperedportion 1230 is linearly tapered off. In one embodiment (notillustrated), width 1240 of fastener blank 130 is substantially equal towidth 1270 of fastener blank 130. Fastener blank 130 may be threadedacross all or a portion of height 1260.

Fastener blank 130 may be configured and dimensioned to extend apredetermined length within aperture 120. In one embodiment, fastenerblank 130 is configured to substantially fill aperture 120. In oneembodiment, fastener blank 130 substantially or completely fillsaperture 120 but does not protrude from body 110 or implant 100. Forexample, as illustrated in FIG. 4, fastener blank 130 has a first end410 and a second end 420 that are coterminous with a first face 430 andsecond face 440 of implant 100. In one embodiment, fastener blank 130has a length that is substantially equivalent to thickness 400.

In one embodiment, illustrated in FIG. 4, implant 100 is secured totissue 480 (e.g., bone) with one or more fasteners 200. In oneembodiment a fastener is disposed within at least one of a plurality ofapertures of body 120 and is secured to tissue 480. In one embodiment, afastener blank 130 is disposed within at least one aperture 120 (e.g.,one of the apertures 120 that is not receiving a fastener 200). Asillustrated in FIG. 1, more than one fastener blank 130 is disposedwithin implant 100. As illustrated in FIG. 4, implant 100 includes fourfasteners 200 and one fastener blank 130. In one embodiment, fastenerblank 130 is configured to align with a fracture 470 within tissue 480.To achieve the beneficial affect described herein, a fastener blank 130can be applied in any other position of a plate where the biomechanicalsituation allows for it.

In some embodiments, implant 100 comprises a material that is degradable(e.g., a degradable metal or polymer). Degradable metals that are usefulin the present invention include magnesium and degradable iron and theiralloys. In one embodiment, implant 100 comprises at least two differentmaterials (e.g., two different metals having a different electrodepotential or electrochemical potential. Magnesium, for example, has astandard electrode potential of −2.37 V; Iron has a standard electrodepotential of of −0.44 V.). For example, in one embodiment, body 110 maycomprise or substantially consist of a material having a first nobilityand a fastener blank 130 comprising or consisting essentially of asecond material having a nobility that is different from the firstmaterial. In one embodiment, the first material is more noble than thesecond material. In another embodiment, the second material is morenoble than the first embodiment. In one embodiment, the second materialis an alloy of the first material. In a further embodiment, the secondmaterial is not an alloy of the first material.

Thus, for example, implant 100 may include a plate having a body 110consisting essentially of magnesium and a fastener blank 130 consistingessentially of a magnesium alloy. Such alloys may include Yttrium and/orrare earth containing alloys such as WE43 or WE54. In one embodiment,implant 100 comprises two metals that are both alloys.

Alternatively, implant 100 may include a plate having a body 110consisting essentially of magnesium, iron or alloys thereof and afastener blank consisting essentially of a more noble metal such as goldor silver. In one embodiment, the presence of the more noble metalpermits the degradation of body 110 faster than it would degrade withoutthe more noble material.

Thus, embodiments of the present invention may provide severaladvantages. For example, in one embodiment, implant 100 may be implantedwith a degradation characteristic that is controlled based upon thematerials selected and the designed features of the implant. Forexample, whereas a prior art magnesium implant 100 implanted for thepurpose, for example, of reducing a fracture, is a bone plate. The platemay include apertures 120 that accommodate bone screws fixing the plateto bone. Prior to the present invention, plate apertures 120 may havebeen left open in proximity of the fracture. In that instance, platedegradation might occur from both sides of plate aperture 120 and may behastened from the interior of the plate. In one embodiment of thepresent invention, fastener blanks fixed within otherwise open apertures120 may retard or substantially eliminate that degradation.Alternatively, fastener blanks comprising material that is moredegradable than the material making up body 110 may be implanted. Insuch case, the more degradable fastener blank may be sacrificiallydegraded in order to further retard the degradation of body 110.

The control of degradation disclosed herein is not limited to implantshaving fastener blanks. For example, in one embodiment there is a tissueimplant 100 (e.g., as illustrated FIGS. 6 and 7) having a body 110 thatcomprises a first material portion 610 and a second material portion620.

In one embodiment, first material portion 610 may comprise or consistessentially of a first material and the second material portion 620 maycomprise or consist essentially of a second material. In one embodimentsuch first material may degrade when exposed to bodily fluids at a ratethat is different than the degradation rate of the second material. Inone embodiment, the second material portion 620 may be configured as asacrificial anode relative to the first material portion 610. In oneembodiment, second material portion 620 may comprise or consistessentially of a less noble metal alloy than that of first materialportion 610. In one embodiment, after the sacrificial anode has beendegraded by, for example, galvanic corrosion, the remaining portion ofimplant 110 may start to corrode/degrade. In one embodiment, secondmaterial portion 620 and first material portion 610 are combined byplating or welding.

In one embodiment, illustrated in FIG. 6, implant 100 (e.g., a plate)includes a main body 630 having a plurality of apertures 120 at leastsubstantially surrounded by the first material 610 and a prolongation605 substantially comprising a second material. In one embodiment,prolongation 605 consists essentially of the second material. In oneembodiment, prolongation 605 includes second material that is platedover first material. Thus for example, prolongation 605 may includefirst material portion 610 surrounded by second material portion 620. Inone embodiment prolongation 605 is welded to main body 630.

In one embodiment, illustrated in FIG. 7, implant 700 (e.g., a plate)includes a main body 730 having a plurality of apertures 120 at leastsubstantially surrounded by first material 610. Implant 700 may alsoinclude segments 705 comprising or consisting essentially of a secondmaterial. In one embodiment, main body 730 comprises or consistsessentially of first material. In one embodiment, second material isplated over the main body at segments 705.

As illustrated in FIGS. 6 and 7, in some embodiments, implant 100, 700includes a boundary 640, 740 between first material 610 and of secondmaterial 620. In one embodiment, boundary 640 extends from one side ofimplant 100, 700 to an opposing side of implant 100, 700. In oneembodiment, boundary 640 comprises a curved boundary. In one embodiment,boundary 640, 740 forms a scalloped feature as illustrated in FIG. 7. Inone embodiment of the present invention, a majority of implant 100, 700(or a majority of body 110) comprises a first material and a minority ofimplant 100, 700 comprises a second material and the first and secondmaterials have different degradation characteristics (e.g., nobility).In one embodiment, the second material includes discrete segmentsrelative to the first material.

In one embodiment, implant 700 includes a second material that is platedin a pattern over first material. In one embodiment, the second materialis electrochemically more noble than the first material. In such anembodiment, the placement of second material may accelerate degradationof implant. In one embodiment, for example, silver may be plated to thetop of a degradable iron implant to accelerate the degradation of theiron implant. For example, the pattern of FIG. 7 reflects a multilobatedboundary. The pattern of FIG. 9 reflects discrete linear segments ofsecond material 620. The exemplary pattern illustrated in FIG. 10reflects discrete segments of second material 620 in the form of dots620, diamonds 930, crosses 940 and logos 950. Discrete segments of otherregular or irregular geometric shapes and lines may also be created.

In one embodiment, illustrated in FIG. 11, second material 620 may beconfigured to provide information 960 to the implanting surgeon. Theinformation for example could provide information 960 regarding theintended placement and/or orientation of implant 100. In one embodiment,information 960 includes material that is more or less noble than thematerial that makes up the balance of implant 100.

FIG. 8 illustrates an exemplary cross-section view of an implant 800 ofthe present invention. In one embodiment, implant 800 is a cannulatedfastener. Implant 800 may include a main body 880 having a head 810, ashaft 820 (that may or may not be threaded) and a cannula 830 extendingthrough head 810 and shaft 820. Implant 800 may also include a socket840 that may be contiguous with cannula 820.

In one embodiment, implant 800 also includes an insert 850 that may beconfigured to fit within cannula 830. In one embodiment, insert 850 isclosely fit to cannula 830. In one embodiment, insert 850 includes ashaft 860 and may include a cap 870. In one embodiment, cap 870 iscontiguous with shaft 860.

Though FIG. 8 illustrates cap 870 protruding from one end of implant 800and not filing the entirety of socket 840. Other configurations arewithin the scope of the present invention. In some embodiment, forexample, insert 850 is configured to substantially fill cannula 830and/or socket 840. In one embodiment, insert 850 is a wire insert thattightly fits within cannula 830. In some embodiments, the cap 870 is“hammered-in” to improve the contact between main body 880 and insert850.

In one embodiment, the present invention includes a method ofcontrolling the degradation of an implant. In one embodiment, the methodincludes providing an implant (e.g., an implant that might include aplate or a cannulated screw) having at least one aperture. In oneembodiment, the implant of the method has a body that consistingessentially of a first material. The method further includes securingthe implant to tissue. In one embodiment, the method includespositioning an insert within the aperture to substantially fill theaperture, the insert consisting essentially of a second material that isof a lower nobility than the first material.

In one embodiment, the method includes providing a first implant (e.g.,an implant that might include a plate) having a plurality of aperturesand at least one fastener blank. The method might include insertingfasteners through some but not all of the apertures to secure the plateto the bone. After securing the plate to the bone, the method mightfurther include permitting the at least one fastener blank to beinserted in at least one of the plurality of apertures that do notcontain an inserted fastener.

Thus, embodiments of the present invention may provide severaladvantages. For example, in one embodiment, implant 100 may be animplant with a degradation profile that is controlled based upon thematerials selected and the designed features of the implant. Thus,whereas a prior art magnesium implant 100 implanted for the purpose, forexample, of reducing a fracture, is a bone plate. The plate may includeapertures 120 that accommodate bone screws fixing the plate to bone.Prior to the present invention, plate apertures 120 may have been leftopen in proximity of the fracture. In that instance, plate degradationwould be hastened from the interior of the plate to the exterior of theplate as bodily fluids contact the inner face of implant 100 (e.g., theface defining apertures 120). In one embodiment of the presentinvention, fastener blanks 130 fixed within otherwise open apertures 120may retard or substantially reduce that degradation. Alternatively,fastener blanks 130 comprising material that is more degradable than thematerial making up body 110 may be sacrificially degraded in order tofurther retard the degradation of body 110.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments shown and described above withoutdeparting from the broad inventive concept thereof. It is understood,therefore, that this invention is not limited to the exemplaryembodiments shown and described, but it is intended to covermodifications within the spirit and scope of the present invention asdefined by the claims. For example, specific features of the exemplaryembodiments may or may not be part of the claimed invention and featuresof the disclosed embodiments may be combined.

It is to be understood that at least some of the figures anddescriptions of the invention have been simplified to focus on elementsthat are relevant for a clear understanding of the invention, whileeliminating, for purposes of clarity, other elements that those ofordinary skill in the art will appreciate may also comprise a portion ofthe invention. However, because such elements are well known in the art,and because they do not necessarily facilitate a better understanding ofthe invention, a description of such elements is not provided herein.

Further, to the extent that the method does not rely on the particularorder of steps set forth herein, the particular order of the stepsshould not be construed as limitation on the claims. The claims directedto the method of the present invention should not be limited to theperformance of their steps in the order written, and one skilled in theart can readily appreciate that the steps may be varied and still remainwithin the spirit and scope of the present invention.

1-12. (canceled)
 13. A method of controlling the degradation of a tissue implant comprising: securing an implant to tissue, wherein the implant has a body consisting essentially of a first material, and the body has at least one aperture; positioning an insert within the at least one aperture to substantially fill the at least one aperture, the insert consisting essentially of a second material that is of a lower nobility than the first material.
 14. A method of controlling the degradation of a tissue implant comprising: inserting fasteners through an implant, wherein the implant comprises a body having a plurality of apertures and wherein the fasteners are inserted through some but not all of the apertures to secure the implant to the tissue; and after securing the implant to the tissue, inserting a fastener blank in at least one of the plurality of apertures that do not contain an inserted fastener.
 15. The method of claim 13, wherein the implant is a plate.
 16. The method of claim 13, wherein the insert does not protrude from the implant.
 17. The method of claim 13, wherein the tissue comprises bone.
 18. The method of claim 13, wherein the insert comprises a screw head.
 19. The method of claim 13, wherein the first material and second material are metallic.
 20. The method of claim 19, wherein the first material is magnesium and the second material is a magnesium alloy.
 21. The method of claim 14, wherein the implant is a plate.
 22. The method of claim 14, wherein the fastener blank does not protrude from the implant.
 23. The method of claim 14, wherein the tissue comprises bone.
 24. The method of claim 14, wherein the fastener blank comprises a screw head.
 25. The method of claim 14, wherein the fastener blank consists essentially of a material that has a different nobility than the body. 